By Dr G Shreekumar Menon
Mangaluru, March 1, 2025: Drug addicts in India are turning to new drugs, namely Tapentadol, Nitrazepam, Pregabalin, Carisoprodol, Zopiclone; Zolpidem; Tapentadol; Naloxone; Pregabalin; Xylazine; Fentanyl; Norfentanyl; Piperidine and Ibloc Piperidine (Fentanyl analogues). Tapentadol, which is a centrally acting opioid analgesic is used for the management of moderate to severe pain for both acute (following injury, surgery, etc.) and chronic musculoskeletal pain. It works by acting on the opioid receptors in the brain and spinal cord, thereby altering the way the body perceives and responds to pain. Due to its potential for abuse and addiction, Tapentadol has been classified as a Schedule H1 drug under the Drugs and Cosmetics Act. Schedule H1 drugs are those that have a high potential for abuse or indiscriminate use and are subject to stricter regulations regarding their sale. The inclusion of ‘Tapentadol’ in Schedule H1 means that it can only be sold by retail pharmacies with a prescription from a registered medical practitioner. Both oral and recently nasal spray formulations of Tapentadol are available in many Asian countries, including India, United States, Australia, and Europe for over a decade. Anyone who uses Tapentadol risks becoming dependent on it, even those who thoroughly follow their doctor’s instructions. Some common physical symptoms of Tapentadol abuse and addiction include, seizures, appetite loss, slurred speech, breathing difficulties, impaired coordination, and sudden, unexplained weight loss. Depression, anxiety, mood fluctuations, and other psychological symptoms may also indicate an addiction to Tapentadol.
In December 2024, the Tumkur police, in Karnataka cracked down on drug peddlers and booked 32 cases and seized 1,720 Tapentadol and Aspadol tablets. Misuse of Tapentadol has been reported from Kovai (Coimbatore) also. In May 2024, a conservative estimate showed that the Chennai city police, on an average, might be seizing at least 5,000 tablets like Nitrazepam and Tapentadol every month. According to official data, the Chennai Greater Police seized more than 52,612 tablets in 2022. Youngsters, mostly school and college students, mix the tablets with distilled water and inject them into their veins or consume them by mixing it with chocolate to get a high.
India banned two highly-addictive opioids in response to a BBC investigation which found they were fuelling a public health crisis in parts of West Africa. BBC Eye found one pharmaceutical company, Aveo, had been illegally exporting a harmful mix of Tapentadol and Carisoprodol to countries like Ghana, Nigeria, and Cote D’Ivoire. The combination of the two drugs is not licensed for use anywhere in the world as they can cause breathing difficulties and seizures and an overdose can kill. Publicly-available export data show that Aveo Pharmaceuticals, along with a sister company called West Fin International, had shipped millions of these tablets to Ghana and other West African countries.
The BBC World Service also found packets of these pills with the Aveo logo for sale on the streets of Nigeria, and in Ivoirian towns and cities. Nigeria, with a population of 225 million people, provides the biggest market for these pills. It has been estimated that about four million Nigerians abuse some form of opioid, according to the nation’s National Bureau of Statistics.
Despite the risks, these opioids are popular street drugs in many West African countries, because they are cheap and widely available. They are also sold in different brand names such as Taamdol 225mg, Taramaking Tafrodol, TimaKing and Super Royal-225.
A total of 81 new synthetic opioids appeared in the European drug market since 2009. These are often highly potent and carry a significant risk of poisoning and death. In 2023, six of the seven new synthetic opioids reported for the first time to the EU Early Warning System (EWS) (EWS) were Nitazenes. Nitazenes are sometimes sold as ‘synthetic heroin’ and have been detected in fake medicines on the drug market. In 2023, Nitazenes were associated with a sharp rise in deaths in Estonia and Latvia and with localised poisoning outbreaks in France and Ireland. Outside the EU, they have been linked to drug overdoses in Australia, North America and the UK. Currently, Nitazenes and similar substances may not be detected in routine post-mortem toxicology tests in some countries, so associated deaths may be under-estimated. New synthetic opioids have been found in different mixtures containing new benzodiazepines or the animal sedative Xylazine. These combinations, respectively known as ‘benzo-dope’ and ‘tranq-dope’, have been linked to poisonings, including deaths, in North America.
Most of the Tapentadol Hydrochloride exports from the World go to Ghana, Nigeria, and Sierra Leone. As of August 2024, globally, the top three exporters of Tapentadol Hydrochloride are India, Italy, and Germany. India leads the world in Tapentadol Hydrochloride exports with 909 shipments, followed by Italy with 24 shipments, and Germany taking the third spot with 14 shipments.
There has been a rise in Tapentadol drug addiction incidence in Bangalore city, with the number of cases seen at NIMHANS crossing 100 in 2024. Tydol tablets, a Tapentadol drug, is used by some people, mostly youths, to get high. NIMHANS data from its Centre for Addiction has been seeing 15-20 such cases every month over the past three years. Most of these patients are from Bengaluru, with a few from other districts of Karnataka and also from Tamil Nadu, Telangana and Kerala. The drug is mostly consumed by youth aged between 18 and 30 years, from poorer sections of society. Youngsters end up consuming at least six tablets a day, spending up to Rs 2,000 daily. The most difficult aspect is managing withdrawal symptoms and the chances of relapse are high, as these substances cause a very high degree of addiction.
Following an alarming rise in drug abuse in the districts bordering Punjab, Haryana Police have written to Narcotics Control Bureau (NCB) in February 2024 to bring “Pregabalin” and “Tapentadol” drugs under the ambit of Narcotic Drugs and Psychotropic Substances Act (NDPS), 1985. Haryana Police said the proposed request is not just a regulatory adjustment, but a necessary step in addressing a growing public health concern. Police said the “unchecked abuse” of “Pregabalin” and “Tapentadol” has far-reaching consequences, impacting individuals, families and society at large, as it disrupts lives, exacerbates health issues and strains healthcare resources. Police said the informal nickname “Budweiser” attributed to “Pregabalin” highlights its intoxicating effects, mirroring alcohol-induced states, while “Tapentadol”, considered as a stronger alternative to “Tramadol” (pain-relief medicine), is increasingly being abused, particularly by those with a history of addiction.
Current legal framework does not classify these drugs under the stringent categories of narcotic drugs and psychotropic substances, leading to a regulatory void in their control and distribution. The Department of Pharmaceuticals has sought urgent details from the health ministry and industry on 10 medicines it suspects are being widely abused. The medicines, which include Fentanyl, Norfentanyl, Zopiclone, Zolpidem, Tapentadol and Naloxone, are used for pain management and treatment of patients with neurological problems. However, although they are prescrption drugs, they can be used as narcotics and abused. The department is seeking to bring them under the Narcotic Drugs and Psychotropic Substances Act (NDPS). This is the practice followed in Europe, US, Canada, Japan and Australia. Notably, none of these medicines are currently listed in the United Nations Conventions on Narcotics Drugs except Fentanyl and consequently not controlled in India, as of now.
Tapentadol has been categorized in the US under Schedule II of the Control Substances Act. In India it is kept under surveillance and is being analysed for its scheduling under the NDPS Act, 1985.
Dr. G. Shreekumar Menon, IRS (Rtd), Ph.D. (Narcotics)
Former Director General of National Academy of Customs Indirect Taxes and Narcotics & Multi-Disciplinary School Of Economic Intelligence India; Fellow, James Martin Centre For Non Proliferation Studies, USA; Fellow, Centre for International Trade & Security, University of Georgia, USA; Public Administration, Maxwell School of Public Administration, Syracuse University, U.S.A.; AOTS Scholar, Japan. He can be contacted at shreemenon48@gmail.com